CLINICAL TRIALS PROFILE FOR ACTHREL

All Clinical Trials for ACTHREL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00756925 ↗	Gender and Neural Substrates of Stress and Craving	Completed	Medical University of South Carolina		2009-02-01	Cocaine dependence is an insidious disease underscored by a powerful proclivity to relapse despite an individual's ability to recognize the deleterious consequences of continued drug use. To date, there are only a limited number of treatments, and no FDA approved medications for the treatment of cocaine dependence. Attempts to find reliable and successful treatments for cocaine dependence may be marred by gender differences in brain chemistry, structure, and function that are manifested as drug craving and relapse. For example, cues, drug exposure, and stress promote relapse, yet females appear be more susceptible to stress induced relapse, while males may be more susceptible to cue induced relapse. Therefore identifying the neural substrates involved in processing the valence of internal and external stimuli may provide further insight into cocaine dependence and provide more effective therapeutic strategies aimed at preventing relapse. Corticotropin releasing hormone (CRH) is a pharmacological activator of the hypothalamic pituitary adrenal (HPA) axis, and has been implicated in stress induced drug relapse. Corticotropin releasing hormone receptors are located at extrahypothalamic brain nuclei that have been implicated in determining the significance of both internal (somatic) and external (environmental) stimuli. The primary directive of this pilot project is to utilize functional magnetic resonance imaging (fMRI) to identify possible brain nuclei associated with with stress induced drug craving in cocaine dependent females.
NCT01373372 ↗	Corticotropin Releasing Hormone (CRH) Responsiveness in Children With Functional Dyspepsia	Withdrawn	Children's Mercy Hospital Kansas City	N/A	2016-12-01	Chronic abdominal pain is the most common persistent pain condition in children and adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that does not get better by going to the bathroom. For some people it appears that stress can make FD worse. In adults, stress can cause the release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can cause abdominal pain by affecting how fast things move through a person's stomach and intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness of the inside lining of the stomach and intestines. Different people react differently when the body releases CRH. Some people have abdominal pain without feeling any stress or anxiety while other people who have a lot of stress or anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or abdominal pain when CRH is released into the body. In order to see how the bodies of children with functional dyspepsia and those without functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation test is routinely done in endocrine patients. It is not routinely done for patients with functional dyspepsia or for patients who do not have functional dyspepsia. Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel® (brand name for Corticorelin), as injection. Acthrel® has been approved by the Food and Drug Administration (FDA) for use. The purpose of this research study is to see if there are differences in how the bodies of children with functional dyspepsia react to CRH versus children who don't have functional dyspepsia. Being in this study involves one clinic visit where an IV placed and a CRH stimulation test. In this test the child will be given an injection of CRH and then observed for one hour. During that hour the child will have five blood draws through the IV and will be asked questions about their anxiety and abdominal pain. This visit will take about 4 hours. The following things will happen: - Your child will be asked to come to the clinic between 8a.m. and 10a.m. fasting. This means your child will have had nothing to eat or drink for 8 hours before coming to the clinic. - If your child is a female ten years of age or older, or has started having periods, a urine pregnancy test will be done before receiving the CRH infusion. - You and your child will each be asked to complete a survey that measures your child's anxiety. - Your child will have a biofeedback session that will measure your child's stress. In a biofeedback session, sensors are placed on your child's fingers, wrists and forehead. These sensors are connected to a computer that monitors your child's heartbeat, skin temperature and electrical pulses on your child's skin. - Your child will have an IV inserted into a vein in his/her arm. Your child may have a cream put on their arm to help with the pain of the IV insertion. The IV will be used to inject the CRH and draw blood. If the IV stops working and blood samples can no longer be drawn from it, your child may have another IV started or blood samples may be drawn by needle stick. - Your child will then have 30 minutes to relax. - Your child will then have CRH infused through the IV over one minute. - Your child will have blood drawn through the IV five times; right before the CRH stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The total amount of blood drawn for the study will be about 2 ½ tablespoons. - Your child will be asked about their abdominal pain, nausea, bloating, stress and anxiety at three separate times during the 60 minutes. - Your child's heart rate will be measured throughout the CRH stimulation test.
NCT01459237 ↗	Effects of Hormone Stimulation on Brain Scans for Cushing s Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Early Phase 1	2011-10-11	Background: - Cushing s disease can be caused by a tumor of the pituitary gland, a small gland about the size of a pea located at the base of the brain. These tumors produce high levels of hormones, which cause obesity, diabetes, and growth problems. The cure for this type of Cushing s disease is to have surgery that removes the tumor but leaves the pituitary gland alone. Currently, magnetic resonance imaging scans are the best way to find these tumors. However, many of these tumors do not show up on the scan. - Positron emission tomography (PET) scans use radioactive chemicals to light up parts of the body that are more active, such as tumors. Researchers want to try to make the small Cushing s disease tumors more active to help them show up on the scans. A special hormone will be given before the scan to make the tumors more active. Objectives: - To test the use of hormone stimulation to improve brain scans for Cushing s disease tumors. Eligibility: - Individuals at least 8 years of age who will be having surgery to remove Cushing s disease tumors. Design: - Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. - They will have three brain scans before surgery. The first scan is a magnetic resonance imaging scan to show a full picture of the brain. The second and third scans are PET scans. - The first PET scan will be given without the special hormone. The second PET scan will be done more than 24 hours but less than 14 days after the first PET scan. The second PET scan will be given with the special hormone. - Participants will have tumor removal surgery through another study protocol.
NCT01673087 ↗	Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures	Completed	University of Michigan	Phase 1	2012-10-01	Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient way to evaluate the biological impact of day-to-day stressors that people encounter as they go about their lives, since saliva is so easy to collect. However, the biological meaning of saliva cortisol measures has never been carefully examined. The goal of this study is to collect saliva from a large group of people as they go about their every-day lives, to measure their cortisol levels, and then study them in the laboratory where Investigators can learn more about how their stress response system (which produces cortisol) is really functioning. Investigators can then determine much more precisely what saliva cortisol levels really mean in terms of stress system biology. This will allow investigators to obtain much more useful information from the next decade of research on naturalistic stress and its biological impact using saliva cortisol measures, helping investigators to understand how stress undermines health and how to combat this effect.
NCT03142893 ↗	Hormonal Mechanisms of Sleep Restriction - Axis Study	Active, not recruiting	Los Angeles Biomedical Research Institute	Phase 1	2017-05-08	The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
NCT03142893 ↗	Hormonal Mechanisms of Sleep Restriction - Axis Study	Active, not recruiting	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 1	2017-05-08	The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Clinical Trial Conditions for ACTHREL

Condition Name

Condition Name for ACTHREL
Intervention	Trials
Sleep Restriction	2
Cocaine Dependence	1
Cushing's Disease	1
Functional Dyspepsia	1

Condition MeSH

Condition MeSH for ACTHREL
Intervention	Trials
Pituitary Neoplasms	2
Pituitary Diseases	2
Gastritis	1
Dyspepsia	1

Clinical Trial Locations for ACTHREL

Trials by Country

Trials by Country for ACTHREL
Location	Trials
United States	7

Trials by US State

Trials by US State for ACTHREL
Location	Trials
California	2
Maryland	2
Michigan	1
Missouri	1
South Carolina	1

Clinical Trial Progress for ACTHREL

Clinical Trial Phase

Clinical Trial Phase for ACTHREL
Clinical Trial Phase	Trials
Phase 1	2
N/A	2
Early Phase 1	2

Clinical Trial Status

Clinical Trial Status for ACTHREL
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for ACTHREL

Sponsor Name

Sponsor Name for ACTHREL
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	2
Los Angeles Biomedical Research Institute	2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	2

Sponsor Type

Sponsor Type for ACTHREL
Sponsor	Trials
Other	7
NIH	2